A single-blind, placebo controlled, randomised study to evaluate antiviral activity and safety and pharmacokinetics of inhaled PC786 against respiratory syncytial virus (RSV) in healthy adult subjects in a virus challenge model

Pulmocide Ltd0 个研究点目标入组 56 人开始时间: 2017年7月14日最近更新: 2019年2月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Pulmocide Ltd
入组人数: 56

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•1. Subject must be male or female, aged between 18 and 55 years inclusive (at the time of consent) who fit one of the following criteria
•Women of childbearing potential who have a documented menstrual period within 28 days prior to first dose.
•Women of non-childbearing potential defined as being amenorrhoeic for >12 months with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms).
•Men who are willing and able to use one of the contraception methods described in the protocol, from the time of the date of Viral Challenge, until 90 days after receipt of the final dose of study medication.
•2. Sero-suitable to the challenge virus
•3. In good health with no history of major medical conditions that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests and determined by the Investigator at a screening evaluation. The following conditions are deemed acceptable:
•Subjects with a history of rhinitis, currently inactive (within the last 30 days and not required nasal corticosteroids in this time) or with ongoing mild rhinitis may be included at the PI’s discretion
•Subjects with clinically mild atopic eczema/atopic dermatitis and clinically mild psoriasis may be included at the Investigator's discretion (e.g., use of low/mild potency regular topical steroids is acceptable. Eczema in the cubital fossa and/or use of medium to high potency dermal corticosteroids are exclusions)
•Subjects with a physician diagnosed underactive thyroid who have been controlled on treatment for at least 6 months with evidence of a normal thyroid function test (TFT) can be included at the discretion of the PI
•Subjects reporting physician diagnosed migraine can be included as long as there are no associated neurological symptoms such as hemiplegia or visual loss
•Subjects with physician diagnosed mild Irritable Bowel Syndrome (IBS) not requiring regular treatment can be included at the discretion of the PI
•Subjects who have experienced no more than one mild (mild is defined as having been treated with bronchodilators only) episode of wheeze after the age of 12, may be included at the Investigator’s discretion, providing the episode lasted no more than 2 weeks, and ended more than 1 year ago. A history of childhood asthma up to and including the age of 12 years is acceptable provided the subject is asymptomatic without treatment.
•4. A total body weight = 50 kg and Body Mass Index (BMI) = 18 kg/m2 and = 30kg/m2
•5. Females must have a negative serum ß human chorionic gonadotropin (ß-hCG) at screening and a negative urinary pregnancy test at Day –2 or Day –1.
•6. Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
•7. An informed consent document signed and dated by the subject and the Investigator.
•8. Subjects will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening.
•9. Serosuitable to the challenge virus, the serology result obtained suggests that the subject is appropriately sensitive to RSV (RSV-A Memphis 37b virus).

排除标准

•1. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge
•2. Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalised due to epistaxis on any previous occasion
•3. Any nasal or sinus surgery within six months of inoculation
•4. Subjects who have smoked = 10 pack years at any time
•5. Subjects who have smoked < 10 pack years at any time if in the month prior to admission to the Quarantine Unit they have used tobacco in any form or other nicotine-containing products in any form or e-cigarettes
•6. History or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, renal, neurological, psychiatric illness
•Psychiatric illness includes subjects with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis
•Subjects with a history of depression of any severity within the last 2 years will be excluded if the PHQ-9 score is = 4
•Subjects with history of anxiety-related symptoms of any severity within the last two years will be excluded if the GAD-7 score is = 4
•7. Other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations. The following apply:
•Clinically active rhinitis (including hay fever) or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded
•Any concurrent serious illness including history of malignancy that may interfere with the aims of the study or a subject completing the study. Basal cell carcinoma within 5 years of treatment or with evidence of recurrence is an exclusion
•Cluster headache/migraine or prophylactic treatment for migraine is an exclusion
•8. A forced expiratory volume in 1 second (FEV1) < 80% of predicted value (using NHANES reference equations)
•9. Subjects with any history of physician diagnosed and/or objective test confirmed asthma (except as stated in inclusion criterion 3), chronic obstructive pulmonary disease, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology
•10. Twelve-lead ECG recording with clinically relevant abnormalities as judged by the study physician/PI
•11. Positive human immunodeficiency virus, active hepatitis A, B, or C test
•12. Confirmed positive test for drugs of abuse or urinary cotinine at screening or on admission
•13. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study
•14. Presence of cold like symptoms and/or fever, defined as subject presenting with a temperature reading of > 37.5oC on Day -2, Day -1, and/or pre-Challenge on Day 0
•15. Evidence of vaccinations within the 4 weeks prior

研究者

发起方

Pulmocide Ltd

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